虎贞清风胶囊治疗湿热蕴结证急性痛风性关节炎多中心随机双盲对照研究

目的评价虎贞清风胶囊治疗湿热蕴结证急性痛风性关节炎的临床疗效和安全性。方法采用随机、双盲、安慰剂平行对照、多中心、优效性检验临床试验设计。由全国14家医院共收集480例中医辨证为湿热蕴结证急性痛风性关节炎患者，采用分层区组随机化方法，使用SAS软件按3： 1随机分为治疗组（360例）和对照组（120例）。治疗组口服虎贞清风胶囊，对照组口服虎贞清风胶囊模拟剂，两组均每次4粒、每日3次给药，共治疗 3天。在治疗第3天进行疼痛视觉模拟评分（VAS），观察治疗前后关节疼痛VAS评分、中医证候积分、各单项症状消失率、血沉（ESR）、C反应蛋白（CRP）、白细胞（WBC）计数及不良事件发生率。结果 480 例患者中438例纳入全分析集（FAS）进行疗效分析，其中治疗组325例，脱落35例（不良事件2例，失访29例，违背方案2例，缺乏疗效退出试验2例）；对照组113例，脱落7例（失访2例，违背方案5例）。治疗组第3天疼痛VAS评分及差值下降程度均优于对照组，差异均有统计学意义（t =7.241，t =6.452， P<0.01）。治疗组中医证候总有效率91.4%（297/325），优于对照组[68.1%（77/113）]，差异亦有统计学意义（χ2=7.184， P<0.01）；治疗组治疗第3天中医证候评分及差值均少于对照组，差异均有统计学意义（t =7.126，t =6.417， P<0.01）。关节疼痛、关节肿胀、关节发热、关节肌肤颜色、活动不便、关节压痛、发热、口渴、烦躁不安9项症状消失率，除发热症状外，治疗组均高于对照组（P<0.01）。两组ESR、CRP、WBC计数比较，差异无统计学意义（P>0.05）。治疗期间不良事件发生率治疗组24.4%（87/357），对照组24.8%（30/121），差异无统计学意义（χ2=0.009，P>0.05）。结论虎贞清风胶囊可有效缓解急性痛风性关节炎（湿热蕴结证）关节疼痛，起效时间短，但安全性与安慰剂相当，临床应用较安全。

英文摘要:

Objective To evaluate the clinical efficacy and safety of Huzhen Qingfeng Capsule （HZQFC） in the treatment of acute gouty arthritis patients with damp-heat accumulation syndrome （DHAS）.Methods A randomized， double-blind， placebo-controlled， multicenter， superiority testing clinical trial was performed. A total of 480 acute gouty arthritis patients with DHAS were collected from 14 hospitals across China. They were randomly assigned to the treatment group （360 cases） and the control group （120 cases） using SAS Software at 3： 1 by stratified block randomization. Patients in the treatment group took HZQFC， while those in the control group took HZQFC simulators. All patients took 4 capsules each time， 3 times a day， for a total of 3 days. The visual analogue scale （VAS） of pain， TCM syndrome score， the disappearance rate of each symptom， erythrocyte sedimentation rate （ESR）， C-reactive protein （CRP）， blood routines （white blood cell count）， and the incidence of adverse events were observed before and after treatment. Results Of 480 subjects， 438 were included in the full analysis set （FAS） for efficacy analysis. There were 325 cases in the treatment group with 35 cases dropped off （including 2 cases with adverse events， 29 lost to follow-ups， 2 cases violating the protocols， and 2 cases withdrawn from the trial due to lack of efficacy）. There were 113 cases in the control group with 7 cases dropped off （including 2 cases lost to follow-ups and 5 cases violating the protocols）. The VAS score and difference of pain in the treatment group on the third day were better than those in the control group， and the differences were statistically significant（t =7.241， t =6.452， P<0.01）. The total effective rate of TCM syndrome in the treatment group was 91.4% （297/325）， better than that [68.1% （77/113）] in the control group with statistical difference （χ2=7.184， P<0.01）. The TCM syndrome scores and differences of the treatment group on the third day were better than those of the control group， and the differences were statistically significant （t =7.126， t =6.417， P<0.01）. In terms of the disappearance rate of 9 individual symptoms， including joint pain， joint swelling， joint fever， joint skin color， mobility inconvenience， joint tenderness， fever， thirst， restlessness， the disappearance rate of the treatment group was higher than that of the control group except fever （P<0.01）. After 3 days of treatment there were no significant differences in ESR， CRP， or WBC count between the two groups （P>0.05）. The incidence of adverse events during the treatment was 24.4% （87/357） in the treatment group and 24.8% （30/121） in the control group， and the difference was not significant（χ2=0.009，P>0.05）.Conclusions HZQFC effectively relieved joint pain of acute gouty arthritis patients with DHAS， with shorter onset time. But its safety was comparable to placebos. So the clinical application was safe.

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